MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERT HANDLE; APPLIANCE,FIXATION,NAIL

Catalog Number	03.168.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a surgery for fracture with fns.During the surgery when the surgeon connected the insertion handle, insert, plate and bolt, he could not tighten the black screw of the insert because it was stuck.He tried changing the angle after untightening the screw, but the problem did not improve.He tightened the screw forcibly and the surgery was completed successfully.The screw could be rotated smoothly when he disassembled.The surgery was delayed by less than 30 minutes.The sales rep checked the device after the surgery, but he could not reproduce the problem.No further information is available.This complaint involves four (4) devices.This is 1 of 4 for report (b)(4).
Additional Manufacturer Narrative
(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.(b)(6).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6 investigation summary visual inspection: upon visual inspection of the complaint device it can be seen that the instrument has a few signs use, but is otherwise in a good condition.Functional test: during investigation a functional test was performed.The two (2) returned instruments passed the functional test.Unfortunately, we could not reproduce the reported problem.Dimensional inspection: the article has passed the function test, no issue could be confirmed, and therefore no dimensional inspection is needed.Document/specification review: the article has passed the function test, no issue could be confirmed, and therefore no document/specification review is needed.Summary: as reported: the sales rep checked the device after the surgery, but he could not reproduce the problem.Unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 03.168.008, lot: 170270-103, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 02.Nov.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERT HANDLE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9377155
• Report Number: 8030965-2019-70571
• Device Sequence Number: 19608864
• Product Code: KTT
• UDI-Device Identifier: 07611819657342
• UDI-Public: (01)07611819657342
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.168.008
• Device Lot Number: 170270-103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 12/23/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1